Table 4.
Model-estimated sarilumab steady-state exposure
| Parameter, mean ± SD | Sarilumab 150 mg q2w |
Sarilumab 200 mg q2w |
|---|---|---|
| AUC0–14d (day·mg/L) | 202 ± 120 | 395 ± 207 |
| Ctrough (mg/L) | 6.35 ± 7.54 | 16.5 ± 14.1 |
| Cmax (mg/L) | 20.0 ± 9.20 | 35.6 ± 15.2 |
Estimates were based on NCT01061736 Part B and NCT01709578 phase III studies
LLOQ: 0.294 or 0.313 mg/L
AUC0–14d area under the curve from time 0 to 14 days, Cmax maximum concentration, Ctrough minimum concentration at steady state after repeated dosing, LLOQ lower limit of quantification, q2w every 2 weeks, SD standard deviation